Illuccix was first approved by the FDA in December 2021. The imaging agent is designed to target and “light up” cancerous cells, making it easier for oncologists to determine through a PET scan if the cells have spread to areas outside the prostate.
Read More
The drug has been closely watched by medical professionals and is viewed by financial analysts as a possible blockbuster, with potential annual sales in the billions of dollars.
Read More
The drug, called tirzepatide, has been closely watched by medical professionals and is viewed by financial analysts as possible blockbuster, with potential annual sales in the billions of dollars.
Read More
There’s one more step: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna boosters to even healthy young adults. Its scientific advisers were set to debate later Friday.
Read More
Groups such as the Alzheimer’s Association have pushed Medicare to cover the new Alzheimer’s drugs—including those cleared on an expedited basis—saying that the FDA should be the final arbiter of safety and efficacy of drugs.
A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021.
Kratom was legal in Indiana until 2014, when state lawmakers banned the substance in anticipation of similar action at the federal level. But the FDA has failed to outlaw kratom, despite numerous attempts.
The U.S. Food and Drug Administration is taking aim at a new health hazard: online misinformation. It’s an unlikely role for the 100-year old bureaucratic agency, which has never been known for its communication skills.
The potential move represents the latest government effort to increase use of a medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually.
The U.S. is poised to make COVID-19 vaccinations more like a yearly flu shot, a major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus.
The Food and Drug Administration’s contentious approval of Alzheimer’s drug Aduhelm took another hit Thursday as congressional investigators questioned the integrity of the process.
The report comes in the wake of heavy criticism of the agency’s handling of a formula shortage earlier this year. Food safety experts have long complained that the agency’s food oversight arm has been chronically understaffed and underfunded.
The proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans.
The ruling Wednesday was a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year.
The salmonella bacteria sickens 1.3 million Americans each year, sends more than 26,000 of them to hospitals and causes 420 deaths, according to Centers for Disease Control and Prevention data.
The FDA has found no firm link between diet and dilated cardiomyopathy. Nor has it rejected such a link, and research is ongoing. Publicity surrounding this issue, nevertheless, has shrunk the once-promising market for grain-free dog foods.
The agreement comes one day after the FDA placed a hold on its initial order banning Juul’s products from the market, saying that Juul’s application warranted “additional review.”
An FDA panel voted 19-2 that COVID-19 boosters should contain some version of the super-contagious omicron variant, to be ready for an anticipated fall booster campaign.
The action is part of a sweeping effort by the Food and Drug Administration to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.
Known as “forever chemicals” for their persistence in the environment, PFAS have been used for decades to prevent grease, water and other liquids from soaking through wrappers, boxes and bags.
The FDA and President Joe Biden face mounting political pressure to explain why they didn’t intervene sooner to head off the supply crisis.
FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden.
Months of spot shortages at pharmacies and supermarkets have been exacerbated by the recall at Abbott, which was forced to close its largest U.S. formula manufacturing plant in February due to contamination concerns.
